Overview
Since the introduction of the Pharmacovigilance System Master File (PSMF) in the EU, there has been a significant increase in the requirements for PSMFs or similar documents in many countries worldwide. This practical and interactive workshop is designed for PSMF Managers, coordinators, and staff involved in the creation and maintenance of the PSMF at the country, regional, or global level. It will be particularly beneficial for those new to the role and those seeking to refresh their knowledge on the PSMF.
The workshop aims to share concepts and practical approaches, enabling participants to adopt pragmatic methods for managing their PSMFs across multiple countries and regions. The workshop will be divided into three focused sessions, each led by industry representatives who will facilitate discussions:
Session One: discusses the Experiences and approaches to PSMF management. Session Two: Systems (PSMF management systems as well as those that feed into the various PSMF components).Final Session: PSMF in the audit and inspections situation (preparation, provision and feedback).
The workshop respects confidentiality and proprietary information. Participants are expected to come prepared to share their own learnings and experiences, ensuring that all attendees are better equipped to support the creation and maintenance of the PSMF on a global scale. Information shared during the workshop will be treated confidentially among participants.
AGENDA
- 15:00 -15:30 - Welcome and Introductions: Workshop overview and objectives
- 15:30 -16:50 - Process and Contents Linking to Audit and Inspection Findings
- 16:50 -17:10 - Coffee Break
- 17:10 - 18:50 - Systems – what would the ultimate PSMF system deliver?
- 18:50 - 19:00 - Close Out
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